MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3544550
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Swollen Lymph Nodes/Glands (4432)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent a breast augmentation revision with a mentor memorygel, 550cc silicone breast implant experienced right sided breast lymphadenopathy and symptomatic rupture postoperative.The report stated that the right implant is leaking, and there is a golf ball size lump under her arm.Multiple scans and biopsy were performed.Mentor hasn't received any report as of now.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: na.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on april 03, 2024 indicated that the patient experienced bilateral capsular contractures unknown grade , and bilateral ptosis.As a result, patient also underwent bilateral capsulectomy, mastopexy, and right side lymph node excision.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on march 20, 2024 indicated that the patient underwent bilateral replacements as follow: l cat:smhb545 sn: (b)(6) / r cat:smhb545 sn: (b)(6), on (b)(6) 2024.Patient age at the time of event was 53 years old.Reason for device explant and/or reoperation: lymphadenopathy and symptomatic rupture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on april 22, 2024.The product was returned to mentor for evaluation.Mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the siltex hpg, 550cc breast implant was found to have two tears on the posterior view, one (a) between the union of the shell and patch, and the second (b) within an area of siltex cracking, measuring approximately 0.5 cm.In addition, parallel lines of shell wear were observed on the anterior aspect.Microscopic examination was performed, and the cause of the tear a could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Although no conclusion could be reach on the cause of tear a, the instructions for use contain the following caution: rupture can occur at any time after implantation but is more likely to occur the longer the implant is implanted.The following may cause implant to rupture: stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.The evaluation determined that the possible cause of the rupture b is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.Lymphadenopathy or palpable lymph nodes may be the result of bacterial or viral infection, neoplasm (primary or metastatic), or as the result of an idiopathic inflammatory process or foreign body reaction.There have been reports regarding movements of silicone gel material to lymph nodes even with or without evident of rupture leading to lymphadenopathy.A number of epidemiology studies have evaluated large populations of women with breast implants from a variety of manufacturers and implant models.The studies do not, taken together, support an association of breast implants and a diagnosed rheumatic disease.Other than one study, these studies do not distinguish whether the women had ruptured or intact implants.Because there were no supporting pathology reports or physician consultation summaries forwarded to product evaluation, we are unable to confirm the presence of or the possible etiology of the reported lymphadenopathy.Lymphadenopathy is a known complication associated with this surgery and is referenced in our current product insert data sheet.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 18048868
• Report Number: 1645337-2023-12917
• Device Sequence Number: 12825639
• Product Code: FTR
• UDI-Device Identifier: 00081317001126
• UDI-Public: 00081317001126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 3544550
• Device Lot Number: 6793959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 03/20/2024; 04/03/2024; 04/15/2024; 04/22/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 03/26/2024; 04/04/2024; 04/16/2024; 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White